Kornimate/medical-research-clean huggingface dataset:
early changes of diabetes parameters after obesity therapy

Conditions: Bariatric Surgery Candidate

Summary: the aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.

previous studies have shown, that laparoscopic roux-en-y gastric bypass (lrygb), and also laparoscopic sleeve gastrectomy (lsg) leed to a significant improvement of glucose metabolism and in many cases to a complete remission of diabetes type ii in obese patients. it is still unclear which mechanisms underlie these changes. since the positive effects of bariatric surgery have been investigated within few days after surgical intervention, before significant weight loss has been achieved, the caloric restriction has been discussed as a possible mechanism. the aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients. therefore, the investigator will examine obese patients with diabetes type ii or impaired glucose metabolism regarding possible metabolic changes within few days after bariatric surgery (lsg or lrygb) or caloric restriction only. group i: patients undergoing lsg; group ii: patients undergoing lrygb; group iii (control group): patients undergoing caloric restriction; dietetic, anthropometric, metabolic and hormonal parameters will be measured. primary outcome marker is the insulin sensitivity according to matsuda (misi). the project is a prospective, controlled study. study examinations will be performed before intervention, and one, two, three, four and five days after (start of) intervention, as well after one month.

Eligibility criteria:
inclusion criteria: * bmi (body mass index) ≥ 35 kg/m2 * clinical diagnosis of type ii diabetes or impaired glucose metabolism (prediabetes: hba1c \> 5,7%, fasting glucose in capillary blood \> 110 mg/dl - diagnosed by blood glucose test at the first study examination) * regarding the patients of the surgical groups: indication to surgical therapy of obesity (laparoscopic sleeve gastrectomy or roux-en-y gastric bypass). the indication to surgery is independent of the study. the surgeon decides about that in the clinical routine according to the german s3 guideline. * written consent to participate int he study exclusion criteria: * medication use which affects glucose metabolism, except for diabetes medication (for example: glucocorticoids) * insulin need \>1,0 iu/kg/d * experimental diabetes medication within the last three months * pregnancy * gastrointestinal diseases * uncontrolled hypo- or hyperthyroidism * status after bariatric or other gastrointestinal surgery
avastin and taxotere for esophagogastric cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: the purpose of this study is to determine what effects (good and bad) bevacizumab (avastin) and docetaxel (taxotere), used in combination, have on metastatic gastric and esophageal cancer.

bevacizumab will be administered intravenously in an outpatient clinic once a week, every other week. docetaxel will also be administered intravenously in the outpatient clinic once a week for three out of four weeks. blood tests and vital signs will be performed weekly. after the first eight weeks of therapy a ct scan will be performed to determine and assess the progress of the disease. if therapy is continued, radiological procedures will be performed at week 16 and every 8 weeks thereafter. treatment will be given for a minimum of 8 weeks, as long as the patient does not experience unacceptable side effects. chemotherapy will continue for a year and a half as long as the cancer is responding and there are no unacceptable side effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed, unresectable or metastatic stage iv esophageal or gastric carcinoma * measurable disease greater than or equal to 1cm by spiral computed tomography (ct) scan or greater than or equal to 2cm by other radiographic technique * ecog performance status 0-2 * one prior chemotherapy for metastatic disease permitted * white blood cell count greater than or equal to 3,000/mm * absolute neutrophil count greater than or equal to 1,500/mm3 * platelet count greater than or equal to 100,000/mm3 * hemoglobin greater than or equal to 8.0g/dl * creatinine less than 2.0mg/dl * total bilirubin less than 1.9mg/dl exclusion criteria: * pregnant or lactating women * history or evidence of central nervous system (cns) disease * other active malignancies other than non-melanoma skin cancer or in-situ cervical cancer * history of severe hypersensitivity to docetaxel, bevacizumab or drugs formulated with polysorbate 80. * current, recent or planned treatment with standard chemotherapy, radiation therapy or another experimental therapy. * history of other disease or metabolic dysfunction. * serious, non-healing wound, ulcer, or bone fracture.

Keywords: bevacizumab docetaxel avatax metastatic esophagogastric cancer
hypochlorous acid disinfection prior to cataract surgery

Conditions: Cataract; Endophthalmitis

Summary: antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. this study will investigate the use of hypochlorous acid, a commercially available over the counter (otc) medication to see if this will reduce the bacterial population prior the cataract surgery.


Eligibility criteria:
inclusion criteria: - patients undergoing cataract surgery. exclusion criteria: * age \<18 years old * vulnerable subjects * non-english speakers

Keywords: ocular/eyelid flora
the effect of hmb supplementation on adipose tissue inflammation and metabolism

Conditions: Obesity

Summary: this study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (hmb) on body composition and strength changes during weight loss. when overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. hmb has been shown to preserve muscle mass and strength, and it is thought that hmb may also preserve muscle, bone, and strength during weight-loss.

forty obese men (bmi 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) calorie restricted; 2) calorie restricted and hmb supplemented; 3) no calorie restriction; and 4) no calorie restriction and hmb-supplemented. over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (dxa) body composition and strength will be measured before and after 8-weeks of intervention. blood and urine will be collected and analyzed at 0, 4, and 8 weeks. additionally dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. muscle biopsies will be taken before and after the 8-week study.

Eligibility criteria:
inclusion criteria: * male * non-smoker * body mass index of 35-40 kg/m2 * age 18-40 years * weight stable for past 6 months (\<5 lb. change) * in good health, free of chronic diseases/conditions that may impact measured outcomes * willing and able to consume a weight loss diet * willing and able to consume a daily nutritional supplement (in pill form) * available for scheduled study commitments during the 2 months of study exclusion criteria: * smoke * take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition * weigh greater 300 pounds due to weight, size and depth limitations of equipment * take dietary supplements * have a chronic disease such as: * cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease * severe orthopedic/musculoskeletal or neuromuscular impairments that would contradict exercise * sensory impairments that interfere with following directions * diagnosis if dementia * history of malignancy during the past 5 years * diabetes mellitus

Keywords: muscle bone fat
varenicline for alcohol dependence

Conditions: Alcoholism

Summary: the primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by diagnostic and statistical manual of mental disorders-iv-text revision (dsm-iv-tr) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).


Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age. 2. have a current (past 12 months) dsm-iv-tr diagnosis of alcohol dependence. 3. be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking. 4. be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in english and able to complete the questionnaires required by the protocol. 5. agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. levonorgestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, 9. hormonal vaginal contraceptive ring, and/or 6. be able to take oral medication and be willing to adhere to the medication regimen 7. complete all assessments required at screening and baseline. 8. provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 9. be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study. 10. have a blood alcohol content (bac) by breathalyzer equal to 0.000 when s/he signed the informed consent document. 11. be someone who in the opinion of the investigator would be expected to complete the study protocol. 12. agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.

Keywords: alcohol alcohol abuse alcoholism alcohol dependence varenicline drinking
diaphragm ultrasound evaluation during weaning from mechanical ventilation in the positive covid-19 patient

Conditions: COVID-19 Pneumonia; Diaphragm Disease

Summary: hypoxemic acute respiratory failure is one of the main covid-19 patients complication that lead to in intensive care hospitalization. this complication determines a variable mortality from 25 to 30%. to correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation. mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve covid-19 respiratory failure cause. calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage. basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive. ultrasound is the best method for measuring diaphragmatic work. the aim of this study is to evaluate the diaphragmatic thickening fraction in covid-19 patients admitted to intensive care unit (icu) for acute respiratory failure and to record its function on weaning.

hypoxemic acute respiratory failure in covid-19 patients often leads to necessity of intubation and mechanical ventilation support. complications may be severe as ventilator-induced lung injury (vili) and respiratory infections. weaning process from mechanical ventilation is based on respiratory work reduction and mechanical support to allow patient's respiratory ability to recovery. respiratory muscle strength give an important contribute. ultrasound diaphragmatic evaluation is essential to evaluate patients respiratory capacity as diaphragm atrophy usually suggest a difficult process and weaning failure. covid-19 pneumonia represent a particular type of ards (acute respiratory distress syndrome), in which different mechanism such as interstitial edema and diffuse alveolar damage, ventilation-perfusion mismatch, intrapulmonary shunt play a role/attend the aim of this study is to assess diaphragmatic function in weaning from mechanical ventilation in patients affected from covid-19 respiratory failure and his implications.

Eligibility criteria:
inclusion criteria: * hypoxemic respiratory failure in covid-19 patients during intensive care unit hospitalization * age\> 18 years * weaning by mechanical ventilation exclusion criteria: * tracheostomy, * unstable clinical conditions; * agitation (richmond agitation-sedation scale (rass)≥ + 2) or non-cooperation (kelly matthay scale ≥5); * more than two organ failure * consent refusal

Keywords: diaphragm thickening fraction happy hypoxemia diaphragmatic ultrasound evaluation sars-cov-2 pneumonia
vascular remodeling after living kidney donation study

Conditions: Living Kidney Donation

Summary: vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. the implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. the object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. this approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. these results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.


Eligibility criteria:
inclusion criteria: * candidate to living kidney donation * affiliated to national health insurance * capable of understanding the consequences of participating to the study * written informed consent exclusion criteria: * pregnancy * breastfeeding * allergy to iodinated contrast agents * allergy to echographic gel, allergy to cutaneous dressings * cutaneous lesions preventing the ultrasonography probe to be applied on the skin * participation to a drug trial

Keywords: living kidney donors endothelial function vascular remodeling pulse wave velocity glomerular filtration rate
a study of nystatin in hiv-infected patients

Conditions: HIV Infections

Summary: to evaluate the clinical toxicity, safety, and potential anti-hiv activity of intravenous nystatin in patients with hiv infection who have completed protocol fda 103c. to evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddi) administered in an alternating regimen in this patient population.

patients who have completed protocol fda 103b are offered the option of receiving extended maintenance. patients who have received no prior ddi are treated either with intravenous nystatin alone (at the same dose level administered in fda 103b) or with a regimen of intravenous nystatin and ddi alternating on 3-week cycles. treatment continues for 12 weeks.

Eligibility criteria:
inclusion criteria patients must have: * completed 12 weeks of therapy with intravenous nystatin on protocol fda 103b. * no evidence of toxicity or progression of disease on protocol fda 103b. (see protocol fda 103b for initial entry requirements.) active drug or alcohol abuse.

Keywords: nystatin didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex
effect on acetaminophen metabolism by liquid formulations

Conditions: Acetaminophen Metabolism; Acetaminophen Poisoning; Drug Metabolism by Excipients

Summary: the purpose of this study is to determine whether excipients in the liquid formulation of acetaminophen prevent the formation of the toxic metabolites of acetaminophen.

acetaminophen (apap) poisoning is the most frequent cause of acute hepatic failure in the united states. toxicity requires cytochrome p-450 bioactivation of apap. children are less susceptible to apap toxicity; the current theory is that they have different metabolism than adults. however, children's liquid preparations of apap contain excipients which have been shown to inhibit apap bioactivation in vitro and in rodents. children tend to ingest liquid preparations, which could potentially explain their decreased susceptibility instead of an intrinsically different metabolism. further, our review of poison center epidemiologic data shows that liquid preparations are less toxic in adults. our hypothesis is that excipients in liquid preparations inhibit the bioactivation of apap. the design is a pharmacokinetic cross-over study in humans. healthy adult subjects will be recruited for administration of therapeutic doses of apap in capsule and liquid formulations. plasma via a heplock will be collected at serial time points up to 8 hours and assayed for apap and its metabolites. after a washout period, subjects will receive the same dose of apap in the alternate preparation. the pattern of metabolites, indicating the activity of the bioactivating enzymes, will be compared. a significant difference in p-450 metabolites will support the hypothesis and provide preliminary data for studies in patients who have ingested potentially toxic doses of apap. ultimately, this work could support development of novel antidotal therapy for apap overdose.

Eligibility criteria:
inclusion criteria: * healthy volunteer ages 18-40 * not taking any chronic medications exclusion criteria: * pregnancy * any history of liver disease * frequent alcohol use (2 or more drinks more than 4 times per week) * unable to provide informed consent

Keywords: acetaminophen excipients
manual versus targer-controll infusion in reduction of awareness and dreaming

Conditions: Anesthesia Awareness

Summary: this study compares manual total intravenous anesthesia (tiva) and target-controll infusion (tci) in reduction of awareness and dreaming, and the haemodynamical stability during operation. half of patients will be anesthetized using manual tiva and other half using tci.

awareness is possible in tiva in case of technical failure or prolonged induction phase, tci technology seems to prevent these events. total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. first half will be anesthetized using tiva with manual induction and the second half will be anesthetized using tci. all patients will fulfil modified brice questionnaire one hour after the end of operation.

Eligibility criteria:
inclusion criteria: * glasgow coma scale 15 * asa physical status classification system i - iii * planed surgery for brain tumor to 5 hours * postoperative awakening exclusion criteria: * nyha iii, iv * abuse of stimulating drugs, grass, alcohol dependence * bmi over 40 in females and over 35 in men * propofol alergie * awake operations * postoperative arteficial ventilation

Keywords: anesthesia awareness dreaming in anesthesia total intravenous anesthesia target-controll infusion
strain-encoded magnetic resonance imaging in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the aim of the study was therefore to evaluate whether myocardial deformation imaging performed by senc allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (ami).

cmr was performed in 38 consecutive patients with ami 3±1 days after successful reperfusion using a clinical 1.5 tesla mr-scanner. ten healthy volunteers served as controls. senc is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. measurements were obtained for each segment in a modified 17 segment model. wall motion and infarcted tissue were evaluated semi-quantitatively from ssfp cine sequences and contrast-enhanced-mr-images and were then related to myocardial strain. comparison of peak circumferential strain assessed by senc and mr-tagging was performed.

Eligibility criteria:
inclusion criteria: * patients with ami after successful reperfusion * healthy volunteers in control group exclusion criteria: * no reperfusion

Keywords: ami, reperfusion successful
action towards health equity and improved air quality in the duwamish valley: a multilevel asthma intervention

Conditions: Asthma in Children

Summary: the goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the duwamish valley, seattle, washington. the main question it aims to answer are: * do box fans with filters improve asthma symptoms? * do box fans with filters improve an objective measure used to monitor lung function known as forced expiratory volume during the first second (fev1)? researchers will compare children living in households with high quality filters to those in households with sham filters to see if air quality and asthma symptoms improve. participants will * fill out several questionnaires * monitor their lung function with a peak flow meter * place an air monitor in their homes to monitor indoor air quality * run the box fan when they are at home


Eligibility criteria:
inclusion criteria: * age (6-17 years) * poorly controlled physician diagnosed asthma defined as more than four days with asthma symptoms in the past two weeks, use of asthma rescue medication for more than four days in the past two weeks, or health care utilization due to asthma in the past year (hospitalization, emergency room visit, or unscheduled clinic visit) * living in georgetown and south park neighborhoods of seattle exclusion criteria: * children with unstable housing or shared custody arrangements

Keywords: air quality